# US 12,109,211 B2 · Hydralazine compositions and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,211 B2 - Document ID: US12109211B2 - Status: Granted - Kind: B2 - Application number: 18/146,756 - Filed: 2022-12-27 - Published: 2023-06-29 - Granted: 2024-10-08 - Earliest claimed: 2021-12-29 - Assignees: Endo Operations Limited - Applicants: Endo Ventures Limited - Inventors: Kumaresh Soppimath; Tushar Hingorani; Hari A. Attluri; Harshil H. Jain - Web page: https://patentgrep.com/patent/US12109211B2 ## CPC - A61K 31/502: ortho- or peri-condensed with carbocyclic ring systems, e.g. cinnoline, phthalazine - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A sterile, ready-to-use pharmaceutical composition having hydralazine and/or a salt thereof at a concentration of less than about 20 mg/mL and a solvent comprising an organic co-solvent, wherein the hydralazine and/or salt thereof and the organic co-solvent are provided at a first weight ratio sufficient for the hydralazine and/or salt thereof to have a change in concentration of no more than about 10% after 2 months of storage at 60° C. Also described are methods of making and using the composition. ## Claims ### Claim 1 A sterile, ready-to-use pharmaceutical composition comprising: hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol, wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C. ### Claim 2 (depends on 1) The composition of claim 1, wherein the weight ratio is no more than about 6:1. ### Claim 3 (depends on 1) The composition of claim 1, wherein the co-solvent is provided at a concentration of about 5% v/v. ### Claim 4 (depends on 1) The composition of claim 1, further comprising a buffer. ### Claim 5 (depends on 4) The composition of claim 4, wherein the buffer comprises a citrate buffer, a tartrate buffer, and/or an acetate buffer. ### Claim 6 (depends on 1) The composition of claim 1, further comprising a chelating agent. ### Claim 7 (depends on 6) The composition of claim 6, wherein the chelating agent is selected from the group consisting of ethylenediaminetetraacetic acid, ethylene glycol-bis(β-aminoethyl ether)-N,N,N′,N′-tetraacetic acid, and penta(carboxymethyl)diethylenetriamine. ### Claim 8 (depends on 1) The composition of claim 1, further comprising a tonicity agent. ### Claim 9 (depends on 8) The composition of claim 8, wherein the tonicity agent comprises a pharmaceutically acceptable salt. ### Claim 10 (depends on 1) The composition of claim 1, wherein the composition is provided in a bag. ### Claim 11 (depends on 1) The composition of claim 1, wherein the composition is provided in a bottle. ### Claim 12 (depends on 1) The composition of claim 1, wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 8% after 2 months of storage at 60° C. ### Claim 13 A pre-filled syringe comprising a sterile, ready-to-use pharmaceutical composition, the composition comprising: hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol, wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C. ### Claim 14 (depends on 13) The pre-filled syringe of claim 13, wherein the pre-filled syringe comprises between about 1 mL and 5 mL of the composition. ### Claim 15 (depends on 13) The pre-filled syringe of claim 13, wherein the weight ratio is no more than about 6:1. ### Claim 16 (depends on 13) The pre-filled syringe of claim 13, wherein the co-solvent is provided at a concentration of about 5% v/v. ### Claim 17 A method of treating hypertension comprising administering to a subject in need thereof a sterile, ready-to-use pharmaceutical composition, the composition comprising: hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol, wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C. ### Claim 18 (depends on 17) The method of claim 17, wherein the administering is performed by direct injection from a pre-filled syringe.